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nasdaq:tbph www.theravance.com www.theravance.com Jul 6th, 2019 12:00AM Associate Director, Biostatistics Open Biometrics South San Francisco, CA, United States South San Francisco CA USA Jun 27th, 2019 12:00AM <p><strong>Associate Director, Biostatistics</strong></p> <p> </p> <p><strong>Job Purpose </strong></p> <p>The Associate Director will provide statistical leadership and technical expertise in support of postmarketing and clinical development activities for multiple therapeutic areas. <br> <br> The Associate Director will be responsible to provide strategic and tactical statistical leadership to projectlevel decisions with a focus on overall clinical program development and strategy, pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews and development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting. <br> <br> The Associate Director is encouraged to apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches), support and defend statistical analyses and their interpretations in regulatory agency interactions; author statistical contributions to clinical study reports, regulatory briefing documents and NDA submissions. <br> <br> The Associate Director will partner with cross-functional project teams and other Biometrics functions to meet project deliverables in a timely and scientifically sound manner. <br> <br> <strong>Duties and Responsibilities</strong> <br> <br> The duties and responsibilities include but are not limited to the following: <br> <br> Build partnership with stakeholders within Clinical Development; participate in and support the design, planning and execution of Clinical Development activities such as protocol, statistical analysis plan, reporting and interpretation of clinical study results, and regulatory interactions; · Actively participate in project teams as the Biostatistics lead. Interacts strategically with crossfunctional teams and other functional areas to ensure timely project deliverables; · Maintains consistently high performance standards and quality of work and ensures all clinical development programs meet scientific, regulatory, quality and commercialization requirements; · Provide statistical expertise in the clinical development and lifecycle management activities for all assigned products; · Plans, directs and organizes all statistical activities for the assigned products including study protocol development, statistical methodology, data analysis and interpretation, and ensures clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products <br> · Collaborate with the head of Biometrics and other project statisticians so that activities are aligned with company goals; standards and processes are consistent across all therapeutic areas; · Lead in development and adaptation of new statistical methodology in support of Theravance Biopharma drug development; · Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations; · Lead Biometrics Department Initiatives; · Manage outside statistical CROs and consultants, as needed, maintaining a constant and open communication to make sure timely and quality deliverables. <br> <br> Qualifications · A PhD in statistics or biostatistics with minimum 8 years of clinical development experience in the pharmaceutical/biotech industry. · Experience with regulatory interactions (FDA and/or EMA). · Solid understanding of clinical trial principles and regulatory requirements. · Knowledge of industry data standards. · Proficiency with statistical analysis software such as SAS and/or R. · Effective verbal and written communication and strong interpersonal skills. · Demonstrated ability to work in a team environment. · Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities. · Dynamic self-starter; agile learner; strategic and creative thinker. · Proven ability to work under minimal supervision. · Demonstrated strong problem solving and risk-mitigation skills. <br> <br> Direct Reports This position does not have any direct reports at the present time. It is expected that this position will be highly effective at managing and coordinating Biometrics efforts within the assigned projects for the purposes of achieving project goals. <br> <br> Physical Requirements None. <br> <br> Working Conditions Regular working condition in office area. Full time schedule is expected.</p> <p> </p> Jul 6th, 2019 10:01AM Jul 6th, 2019 10:01AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 6th, 2019 12:00AM Senior Scientist, DMPK Open DMPK South San Francisco, CA, United States South San Francisco CA USA Jun 28th, 2019 12:00AM <p><strong>Job Purpose</strong></p> <p>As a Senior Scientist in the DMPK department, the successful candidate will lead the strategic direction of DMPK efforts on drug discovery and development project teams, working closely with colleagues from other disciplines to design, optimize, and develop locally targeted molecules.</p> <p><strong>Duties and Responsibilities</strong></p> <p>The Drug Metabolism and Pharmacokinetics (DMPK) department at Theravance BioPharma is seeking an experienced Ph.D. level Senior Scientist to support small molecule drug discovery and development programs. Primary responsibilities will be functional lead representation on Theravance Biopharma drug discovery and development project teams where the successful applicant will be required to influence the strategic direction of projects across the entire portfolio.  The candidate will be responsible for <em>in vitro, in vivo and modeling/simulation</em> resources and managing their flexible deployment to support project strategy. This will include the strategic use of CROs to supplement in-house resources as necessary. The candidate will design study protocols, conduct studies, review data and assess need for additional experiments/analysis; author and finalize reports in support of IND submissions. The successful candidate will work closely with colleagues from Biology, Chemistry, Translational Sciences to design impactful preclinical studies with clinical translation in mind.</p> <p>The successful candidate will exhibit an energetic and innovative approach to problem solving. Strong communication/interpersonal skills with a desire to work in a fast-paced, flexible and dynamic environment is required.</p> <p><strong>Qualifications</strong></p> <ul> <li>PhD in Pharmaceutical Science, Pharmacokinetics, Biochemistry, Chemistry or a related Life Science</li> <li>Strong experience leading DMPK discovery and development strategy and working in cross-functional team environments</li> <li>5+ years of progressive industry (pharma, biotech, etc) experience in DMPK</li> <li>Familiarity with IND-enabling studies and clinical drug development</li> <li>Familiarity with localized drug delivery (e.g., GI tract, lung, ocular, dermal) is preferred</li> <li>Excellent written and verbal communication skills</li> </ul> <p><strong>Direct Reports</strong></p> <p>No immediate direct reports but the successful applicant will be anticipated to manage in a matrix-based environment.</p> <p><strong>Physical Requirements</strong></p> <p>The incumbent may be required to sit, stand and walk for extended periods of time.  The incumbent may be required to climb, bend, lift, carry and kneel.  Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment.</p> <p><strong>Working Conditions</strong></p> <p>Being present and productive within normal working hours.</p> Jul 6th, 2019 10:01AM Jul 6th, 2019 10:01AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Research Associate I/II Open Biology & Pharmacology South San Francisco, CA, United States South San Francisco CA USA Apr 25th, 2019 12:00AM <p> </p> <p><strong>Position Summary</strong></p> <p>The department of Biology and Pharmacology is currently seeking a motivated Research Assistant/Associate to participate in drug discovery research. The successful candidate will work collaboratively with senior scientists to develop and execute pharmacodynamic and disease mechanism models designed to assess the pharmacological activity of novel molecules.  The successful candidate should have the ability and willingness to work in a variety of therapeutic areas. </p> <p><strong>Duties and Responsibilities</strong> </p> <p>Research Associate should have strong in vitro / in vivo skills.  Ability to provide scientific inputs for new assay/ experimental model development. </p> <ul> <li>Data collection, evaluation and documentation</li> <li>Rodent handling, dosing, and dissections</li> <li>Basic rodent surgeries</li> <li>Surgical/Assay preparation</li> <li>Assay monitoring</li> <li>Compound formulation, dilutions, dose calculations</li> <li>Use of MS Excel, Word, and Graphpad<sup>®</sup> Prism software</li> <li>Presentation of experimental findings to colleagues</li> </ul> <p> <strong>Qualifications</strong></p> <ul> <li>BS/MS in a relevant scientific discipline, and at least one year of drug discovery experience in a biotechnology/pharmaceutical or academic setting</li> <li>Sound understanding of animal physiology and anatomy</li> <li>Excellent organizational, written and oral communication skills</li> <li>Experience in handling, dosing and induction of anesthesia in small animals</li> <li>Knowledge in vitro assays, multicolor flow cytometry, ELISA, qPCR, MSD-based assays, and AlphaLISA is a plus</li> <li>Ability to work efficiently and independently under minimal supervision in a dynamic team environment</li> </ul> <p><strong>Physical Requirements</strong> </p> <p>The incumbent may be required to sit, stand and walk for extended periods of time.  The incumbent may be required to climb, bend, lift, carry and kneel.  The incumbent will also spend a some time looking at the computer monitors and using his/her hands to operate office equipment.</p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Senior Manager, Supplier Management Open Global Development Operations South San Francisco, CA, United States South San Francisco CA USA May 29th, 2019 12:00AM <p><strong>Purpose:        </strong></p> <ul> <li>Ensure appropriate evaluation and oversight of suppliers</li> <li>Maximize the value obtained from partnerships with external providers at a study, program and supplier level</li> </ul> <p><strong>Context and Responsibilities:</strong></p> <ul> <li>Facilitating and delivering supplier management activities</li> <li>Developing effective partnerships with suppliers</li> <li>Measuring and reporting supplier performance including issue resolution</li> <li>Financial oversight of suppliers across portfolio work</li> <li>Developing Supplier oversight processes and controlled documents</li> <li>Mentoring/training and fostering organization knowledge regarding supplier management</li> <li>Support contract owners with addressing supplier related issues, as necessary</li> <li>Oversee the progress of supplier management related activities on clinical studies and effectively manage timelines for supplier management deliverables.</li> <li>Duties also may include participating in or leading cross functional initiatives aimed at developing or improving supplier management processes </li> </ul> <p><strong>Key Activities: </strong><em>(may be variable depending upon the focus of the role)</em></p> <ul> <li>Ensure quality oversight of suppliers through:</li> <ul> <li>Providing ongoing governance oversight for business critical suppliers and encourage sharing of best practices and development of process improvements</li> <li>Chairing and managing supplier governance meetings</li> <li>Working with suppliers and internal customers to identify, manage, escalate and resolve issues relating to supplier performance</li> <li>Measuring supplier performance and reporting performance feedback to internal stakeholders and suppliers</li> <li>Lead / support supplier related initiatives, as identified by management</li> </ul> <li>Maintain strong working knowledge of suppliers and sourcing strategies within category</li> <li>Ensure quality oversight of GDO managed purchase orders (POs) through:</li> <ul> <li>PO lifecycle management: SoW negotiations, funding request through established financial processes, PO execution, ongoing budget review and PO closure</li> </ul> <li>Ensure oversight of account activations and deactivations of GDO managed suppliers</li> <li>Support business functions with selection and development of new suppliers by:</li> <ul> <li>Identifying business needs at TBPH for new suppliers with functional input</li> <li>Facilitating final decision on selection of suppliers</li> </ul> <li>Identify functional best practices and process improvement and coordinate their development and implementation for suppliers by:</li> <ul> <li>Communicating and standardizing best practices across supplier types</li> <li>Ensuring adherence to best practices by TBPH functional areas</li> </ul> <li>Liaise with functional areas to ensure internal business needs are being met</li> <li>Lead and contribute to complex departmental and cross-functional initiatives and special projects as identified by management or business need</li> <li>Line Managers will also be responsible for staff mentoring, career development, and performance management<strong> </strong></li> </ul> <p><strong>Key Output:</strong></p> <ul> <li>Timely and accurate execution of Supplier Management related documents and processes</li> <li>Documentation of supplier management level decisions made by the team</li> <li>Supplier issue management and resolution</li> </ul> <p><strong>Decision Authority:</strong></p> <ul> <li>Communication of TBPH decisions and best practices to suppliers</li> <li>Escalation of relationship issues</li> <li>Minimal supervision related to projects and activities, soliciting guidance as appropriate</li> <li>Represent GDO in the evaluation of vendors</li> <li>Represent GDO cross-functional supplier management related issues</li> </ul> <p><strong>Basic Qualifications</strong>:</p> <ul> <li>Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment or relevant CRO:</li> </ul> <ul> <ul> <li>Doctorate degree &amp; 2 years of management related experience</li> </ul> </ul> <p>OR</p> <ul> <ul> <li>Master’s degree and 6 years of Management related experience</li> </ul> </ul> <p>OR</p> <ul> <ul> <li>Bachelor’s degree and 8 years of management related experience</li> </ul> </ul> <p>OR</p> <ul> <ul> <li>Associates degree and 10 years of management related experience</li> </ul> </ul> <p>AND</p> <ul> <ul> <li>2 years of direct managerial and/or leadership experience</li> </ul> </ul> <p><strong>Preferred:</strong></p> <ul> <li>BS/BA/BSc in the sciences or RN</li> <li>8 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a pharmaceutical, biotech or CRO company)</li> <li>Experience at, or oversight of, clinical research suppliers (CROs, central labs, imaging suppliers, etc.)</li> <li>Experience managing direct reports </li> </ul> <p><strong>Experience:</strong></p> <ul> <li>Knowledge of Good Clinical Practice (GCP), ICH, FDA regulations and guidelines, and international regulatory requirements/guidelines</li> <li>Experience working in a global, matrix organization</li> <li>Project management/project planning experience</li> <li>Proficiency in anticipating and resolving problems</li> <li>Experience writing and presenting clearly on scientific and clinical issues</li> <li>Excellent interpersonal, organizational, supervisory skills</li> <li>Professional collaboration and leadership skills</li> </ul> <p><strong>Core Competencies:</strong></p> <ul> <li>Relationship building skills</li> <li>Creative problem solving</li> <li>Ability to design and implement business processes that address organizational needs</li> <li>Prioritizing in a dynamic environment</li> <li>Effective skill at balancing competing priorities while managing stakeholder expectations</li> <li>Excellent organizational skills</li> <li>Effective at writing and presenting clearly on scientific and clinical issues</li> <li>Good written and verbal communication skills</li> <li>Negotiation skills</li> </ul> <p><strong>Travel:</strong></p> <ul> <li>Some travel may be required (&lt;30%)</li> </ul> <p> </p> <p><strong> </strong></p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Clinical Study Planner / Senior Clinical Study Planner Open Global Development Operations South San Francisco, CA, United States South San Francisco CA USA Jun 11th, 2019 12:00AM <p>POSITION DESCRIPTION: </p> <p>The Clinical Study Planner / Senior Clinical Study Planner will support the execution of clinical trial related activities, with the primary focus on developing, aligning and delivering timeline and planning related data that directly supports the execution of clinical trials.  Duties will include but not limited to generating aligned outputs across service providers that report key study start-up related details, study execution and study close-out.  All reporting will fit and align within standard milestone tracking and enable clinical study managers, teams and Senior Management a consistent view into study execution.  Further, this individual will work within the Planning and Performance Management Team and with key partners in Supplier Management to regularly generate metrics for both internal study execution and supplier study execution.  This individual will also work directly with the global development operations study management teams to support country and region focused start-up review, including trouble shooting and project management of issue resolution, to facilitate site initiations across our global clinical studies.  Additional activities include: managing master calendar of team activities, maintaining issue tracking/resolution of action items across teams, supporting GDO RACI activities and performing various duties that support effective team utilization of shared reports and trackers.  </p> <p>EDUCATION AND EXPERIENCE: </p> <p>This position, depending upon level, requires at least 8 years relevant clinical research experience including 2 years of clinical study planning or comparable project management experience in Pharmaceutical or Biotechnology company.  Post high school education (e.g., Associates or Bachelor’s Degree) considered a plus.  The ideal candidate will have significant experience in clinical operations which includes starting studies and working in various regions across the globe.  Familiarity with generating data output in Excel and working in Powerpoint are essential for success in this role, including multitasking while maintaining attention to detail.   </p> <p>REQUIRED SKILLS: </p> <ul> <li>Strong, open and transparent communication skills (verbal and written)</li> <li>Highly organized and able to operate and maintain consistent standards</li> <li>Experienced in generating data outputs in Excel</li> <li>Ability to multitask and shift priorities to meet demands of project</li> <li>Ability to deal with time constraints, takes initiative, exercises good judgment, and attention to detail</li> <li>Knows when to escalate to manager</li> <li>Results oriented, flexible, team-oriented</li> <li>Ability to maintain a calm, professional demeanor despite time and project demands</li> <li>Understands importance of consistent and shared information to keep an extended organization aligned</li> <li>Negotiate and maintain positive relationships simultaneously between teams, suppliers and management</li> <li>Proficiency with Microsoft Office Suite, electronic data management systems required</li> </ul> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Sr. Manager - Associate Director, Statistical Programming Open Biometrics South San Francisco, CA, United States South San Francisco CA USA Jun 14th, 2019 12:00AM <p> </p> <p> </p> <h2><strong>J</strong><strong>o</strong><strong>b Purpose                                                                                                                                                                 </strong><strong> </strong></h2> <p>The Statistical Programming Associate Director will be responsible for multiple therapeutic areas or therapeutic indications leadership of a statistical programming group that supports multiple drug development programs.</p> <p>The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will assist the head of Statistical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs.  Serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines.  Provide leadership to the company in the area of technical expertise.</p> <h2>Duties and Responsibilities                                                                     </h2> <h4>The duties and responsibilities include but are not limited to the following:</h4> <ul> <li>Manage a group of statistical analysts, including managers and analysts</li> <li>Act as principle analyst to provide statistical programming service to multiple therapeutic areas</li> <li>Provide review and supervision of the departmental staff in a manner that promotes problem solving, career development, and motivation</li> <li>Develop, revise, and maintain Standard Operating Procedures and Work Instructions</li> <li>Support the Head of Statistical Programming to achieve the company’s goals</li> <li>Develop staff for current and future positions</li> <li>Stay abreast of current regulatory environment focusing on submission standards</li> <li>Provide input in the selection of CROs, manage CRO programming activities for complex studies</li> <li>Lead task forces to develop complex, technical solutions for projects or business needs</li> <li>Independently bring technical solutions to the Statistical Programming department</li> <li>Develop and maintain good communications and working relationships with internal/external functions</li> <li>Ensure that the company business needs and partner organizations are satisfied within agreed- upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies</li> <li>Lead the effort of programming process improvement</li> <li>Assist in validating software products used by the Statistical Programming department</li> </ul> <p> </p> <h2>Qualifications</h2> <ul> <li>A B.S.(or higher) in Statistics, Computer Science or other closely related field to programming with minimum 10-12 years of relevant pharmaceutical/biotech industry experience.</li> <li>At least 6-8 years of demonstrated leadership experience including minimum 3 years in people management; career progression.</li> <li>Direct experience in leading programming in supporting NDA, BLA and EMEA filing</li> <li>Expert experience using industry standards such as CDASH, SDTM, and ADa</li> <li>Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS/GRAPH.</li> <li>Experience in development and implementation of statistical programming standards and procedures is required; knowledge of software systems development is required.</li> <li>In depth understanding of clinical trial principles and regulatory requirements.</li> <li>Expert knowledge of industry data standard</li> <li>Demonstrated ability to manage and lead projects for Statistical Programming and managing program</li> <li>Effective verbal and written communication and strong interpersonal skills.Strong project management skills; flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tas Must work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.</li> <li>Dynamic self-starter; agile learner; strategic and creative thinker.</li> <li>Demonstrated strong problem solving and risk-mitigation skills.</li> </ul> <p><strong> </strong><strong>Direct Reports                                                                                                                                                                                       </strong><strong> </strong></p> <p>This position does not have direct reports currently and is expected that the Manager will be highly effective at managing and coordinating statistical programming efforts in a therapeutic area.</p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Associate Director, Statistical Programming Open Biometrics South San Francisco, CA, United States South San Francisco CA USA Jun 14th, 2019 12:00AM <p> </p> <p> </p> <h2><strong>J</strong><strong>o</strong><strong>b Purpose                                                                                                                                                                 </strong><strong> </strong></h2> <p>The Statistical Programming Associate Director will be responsible for multiple therapeutic areas or therapeutic indications leadership of a statistical programming group that supports multiple drug development programs.</p> <p>The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will assist the head of Statistical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs.  Serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines.  Provide leadership to the company in the area of technical expertise.</p> <h2>Duties and Responsibilities                                                                     </h2> <h4>The duties and responsibilities include but are not limited to the following:</h4> <ul> <li>Manage a group of statistical analysts, including managers and analysts</li> <li>Act as principle analyst to provide statistical programming service to multiple therapeutic areas</li> <li>Provide review and supervision of the departmental staff in a manner that promotes problem solving, career development, and motivation</li> <li>Develop, revise, and maintain Standard Operating Procedures and Work Instructions</li> <li>Support the Head of Statistical Programming to achieve the company’s goals</li> <li>Develop staff for current and future positions</li> <li>Stay abreast of current regulatory environment focusing on submission standards</li> <li>Provide input in the selection of CROs, manage CRO programming activities for complex studies</li> <li>Lead task forces to develop complex, technical solutions for projects or business needs</li> <li>Independently bring technical solutions to the Statistical Programming department</li> <li>Develop and maintain good communications and working relationships with internal/external functions</li> <li>Ensure that the company business needs and partner organizations are satisfied within agreed- upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies</li> <li>Lead the effort of programming process improvement</li> <li>Assist in validating software products used by the Statistical Programming department</li> </ul> <p> </p> <h2>Qualifications</h2> <ul> <li>A B.S.(or higher) in Statistics, Computer Science or other closely related field to programming with minimum 12 years of relevant pharmaceutical/biotech industry experience.</li> <li>At least 8 years of demonstrated leadership experience including minimum 3 years in people management; career progression.</li> <li>Direct experience in leading programming in supporting NDA, BLA and EMEA filing</li> <li>Expert experience using industry standards such as CDASH, SDTM, and ADa</li> <li>Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS/GRAPH.</li> <li>Experience in development and implementation of statistical programming standards and procedures is required; knowledge of software systems development is required.</li> <li>In depth understanding of clinical trial principles and regulatory requirements.</li> <li>Expert knowledge of industry data standard</li> <li>Demonstrated ability to manage and lead projects for Statistical Programming and managing program</li> <li>Effective verbal and written communication and strong interpersonal skills.Strong project management skills; flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tas Must work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.</li> <li>Dynamic self-starter; agile learner; strategic and creative thinker.</li> <li>Demonstrated strong problem solving and risk-mitigation skills.</li> </ul> <p><strong> </strong><strong>Direct Reports                                                                                                                                                                                       </strong><strong> </strong></p> <p>This position does not have direct reports currently and is expected that the Manager will be highly effective at managing and coordinating statistical programming efforts in a therapeutic area.</p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Senior Commercial Analytics Business Analyst Open Information Tech & Informatics South San Francisco, CA, United States South San Francisco CA USA Jun 18th, 2019 12:00AM <p><strong>Job Purpose</strong></p> <p>The Senior Business Analyst for Commercial Analytics is responsible for developing emerging analysis and modeling techniques that will deliver actionable insight to Theravance Biopharma’s Commercial sales team and executive stakeholders.  The ideal candidate will work across multiple data sets and will partner with technical members of IT staff to design and deliver analytical solutions and predictive models to highlight business performance against corporate goals and identify potential business opportunities.                                             </p> <p><strong>Duties and Responsibilities</strong></p> <ul> <li>Ability to work with key business stakeholders to identify, document and clearly communicate business requirements and to translate those requirements into technical terms/solutions</li> <li>Coordinate design and delivery of analytical solutions and predictive models, in close partnership with members of internal and/or external technical staff</li> <li>Improve systems/data environments by studying current practices and designing modifications as necessary</li> <li>Determine operational objectives by studying business functions; gathering information; evaluating output requirements and formats</li> <li>Monitor project progress by tracking activity; resolving problems; publishing progress reports; recommending actions</li> <li>Create informative, actionable and repeatable reporting that highlights relevant business trends and opportunities for improvement</li> <li>Stay up to date on the latest trends and techniques in the analytics space, such as (but not limited to) artificial intelligence (AI) and machine learning (ML)</li> <li>Propose and facilitate meetings with business stakeholders and technical team members and external partners, that assist in planning and delivery of desired solutions</li> <li>Manage tasks associated with stakeholder communication, status reports and data analysis</li> <li>Document business processes, data flows, standard operating procedures and user guides</li> <li>Perform current state and/or future state analysis activities</li> <li>Act as an escalation point for any data analysis related issues </li> </ul> <p><strong>Qualifications</strong><strong>                                                     </strong></p> <ul> <li>7+ years of experience supporting sales teams, marketing analytics and executive management needs</li> <li>5+ years of working experience in life sciences industry (biopharma, biotech, pharma)</li> <li>3+ years of experience as Data Analyst, or a related analytical role</li> <li>Proven communication and interpersonal skills, self-motivated with a sense of urgency, well-organized, strong problem-solving abilities</li> <li>Ability to adapt quickly to changing priorities; highly skilled in working independently and ability to evaluate business from multiple perspectives for organizational profitability and balance of internal/external customer needs.</li> <li>Strong solution oriented team player that has a customer service approach</li> <li>Structured data analysis and data requirements development experience</li> <li>Solid experience performing business/data analysis with Commercial data within life science industry. Examples (but not limited to):</li> <ul> <li>Syndicated Sales (account and prescription levels)</li> <li>Field Roster and Alignment</li> <li>Health Care Professional (HCP) Attendee detail</li> <li>Product and Market data</li> <li>Speaker Bureau and Speaker Event data</li> </ul> <li>Proficient with using Standard Query Language (SQL, or alike) to interact with industrial scale databases (relational, columnar, etc.)</li> <li>Proficiency with industry leading analytical tools (Tableau, ThoughtSpot, Spotfire)</li> <li>Demonstrated intellectual curiosity with data and process improvement</li> <li>Self-starter. Comfortable with a little ambiguity</li> </ul> <p><strong>Preferred</strong></p> <ul> <li>Bachelor's Degree or an equivalent level of education and experience</li> <li>Certification(s) in Data Science and Analytics</li> <li>Experience working with Python and/or R</li> <li>Experience working in cloud environments (AWS preferred)</li> <li>Experience and/or conceptual knowledge of artificial intelligence (AI) and machine learning (ML) trends and techniques</li> <li>Project Management experience (PMP certification highly desirable)</li> </ul> <p><strong>Direct Reports</strong></p> <p>None.  The candidate will report directly to Senior Director of Enterprise Applications.</p> <p> </p> <p> </p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Director/Sr. Director, Clinical Development - Pulmonary Open Clinical Development South San Francisco, CA, United States South San Francisco CA USA Jun 22nd, 2019 12:00AM <p><strong>Job Purpose</strong></p> <p>This position of Director-Clinical Development – Pulmonary, reports to the VP of Clinical Development &amp; Medical Affairs, with medical/clinical responsibilities for our emerging portfolio of products in the respiratory arena.</p> <p><strong>Duties and Responsibilities</strong> </p> <p>The duties and responsibilities include but are not limited to the following: </p> <ul> <li>The primary responsibility of this role will be to provide clinical/medical support to our pulmonary program(s).</li> <li>Using pulmonary background, works to educate and train internal and external stakeholders on the therapeutic area.</li> <li>Demonstrated ability to exercise good medical-clinical judgement in a fast paced and collaborative environment</li> <li>Work collaboratively with cross functional partners (e.g. Clin Ops, Biometrics, Pharmacovigilance, Regulatory, DMPK, Project Management, Medical Affairs, Commercial)</li> <li>Work to develop relationships with External Experts, Investigators, and Clinical Sites.</li> <li>Authors and/or collaborates in the development and review of clinical and regulatory documents (e.g. protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), etc.)</li> <li>Interact with regulatory agencies throughout the development process.</li> <li>Ability to interpret, summarize and communicate clinical data internal and external audiences</li> <li>Maintain a high degree of understanding and awareness on new and emerging developments both in the therapeutic area and in clinical development across the industry</li> <li>If an MD candidate: <ul> <li>Serve as Medical Monitor on clinical trials, and as medical expert for clinical studies</li> <li>Experience in the practice of medicine and medical monitoring experience a plus </li> </ul> </li> </ul> <p><strong>Qualifications</strong></p> <ul> <li>PhD, PharmD, Medical Doctor (MD or equivalent) or other advanced degree. Physicians will be given preference</li> <li>Subject area expert and 5+ years of clinical trial experience or Clinical Development experience in a pharmaceutical or biotechnology setting</li> <li>Ability to communicate with sites and investigators on matters of clinical trial conduct</li> <li>Excellent oral and written communication skills. Confident using online communications and teleconferencing.</li> <li>Ability to communicate with teams across multiple time zones, flexibility in working hours.</li> <li>Comfortable with presenting detailed scientific data to groups, large and small, internally and externally.</li> <li>Demonstrable skills with teaching and educating both professional and lay people.</li> <li>Ability to work on several projects simultaneously.</li> <li>A thorough understanding of medical monitoring, pharmaceutical safety, reporting and surveillance processes</li> <li>A detail oriented professional who is creative and solution-orientated</li> <li>Ability to forge and develop relationships with both internal and external stakeholders</li> <li>Demonstrates strong ability to identify, diagnose and correct issues promptly</li> <li>Willingness to challenge the ‘<em>status quo’ </em></li> <li>A self-motivated individual who is culturally sensitive and emotionally intelligent</li> <li>Ability to fit seamlessly within a dynamic team and fast-paced environment</li> <li>Autonomous, proactive, collaborative and collegiate </li> </ul> <p><strong>Direct Reports</strong></p> <p>None initially, but potential to build and lead a small team as company grows. </p> <p><strong>Physical Requirements</strong></p> <p>The incumbent may be required to sit, stand and walk for extended periods of time.  The incumbent may be required to climb, bend, lift, carry and kneel.  Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment. </p> <p><strong>Working Conditions</strong></p> <p>This position may be based at company offices in either South San Francisco or Dublin, Ireland. Remote working situations may also be considered. Travel of up to 20% of time is expected. </p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology
nasdaq:tbph www.theravance.com www.theravance.com Jul 7th, 2019 12:00AM Associate Director, Biostatistics Open Biometrics South San Francisco, CA, United States South San Francisco CA USA Jun 27th, 2019 12:00AM <p><strong>Associate Director, Biostatistics</strong></p> <p> </p> <p><strong>Job Purpose </strong></p> <p>The Associate Director will provide statistical leadership and technical expertise in support of postmarketing and clinical development activities for multiple therapeutic areas. <br> <br> The Associate Director will be responsible to provide strategic and tactical statistical leadership to projectlevel decisions with a focus on overall clinical program development and strategy, pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews and development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting. <br> <br> The Associate Director is encouraged to apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches), support and defend statistical analyses and their interpretations in regulatory agency interactions; author statistical contributions to clinical study reports, regulatory briefing documents and NDA submissions. <br> <br> The Associate Director will partner with cross-functional project teams and other Biometrics functions to meet project deliverables in a timely and scientifically sound manner. <br> <br> <strong>Duties and Responsibilities</strong> <br> <br> The duties and responsibilities include but are not limited to the following: <br> <br> Build partnership with stakeholders within Clinical Development; participate in and support the design, planning and execution of Clinical Development activities such as protocol, statistical analysis plan, reporting and interpretation of clinical study results, and regulatory interactions; · Actively participate in project teams as the Biostatistics lead. Interacts strategically with crossfunctional teams and other functional areas to ensure timely project deliverables; · Maintains consistently high performance standards and quality of work and ensures all clinical development programs meet scientific, regulatory, quality and commercialization requirements; · Provide statistical expertise in the clinical development and lifecycle management activities for all assigned products; · Plans, directs and organizes all statistical activities for the assigned products including study protocol development, statistical methodology, data analysis and interpretation, and ensures clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products <br> · Collaborate with the head of Biometrics and other project statisticians so that activities are aligned with company goals; standards and processes are consistent across all therapeutic areas; · Lead in development and adaptation of new statistical methodology in support of Theravance Biopharma drug development; · Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations; · Lead Biometrics Department Initiatives; · Manage outside statistical CROs and consultants, as needed, maintaining a constant and open communication to make sure timely and quality deliverables. <br> <br> Qualifications · A PhD in statistics or biostatistics with minimum 8 years of clinical development experience in the pharmaceutical/biotech industry. · Experience with regulatory interactions (FDA and/or EMA). · Solid understanding of clinical trial principles and regulatory requirements. · Knowledge of industry data standards. · Proficiency with statistical analysis software such as SAS and/or R. · Effective verbal and written communication and strong interpersonal skills. · Demonstrated ability to work in a team environment. · Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities. · Dynamic self-starter; agile learner; strategic and creative thinker. · Proven ability to work under minimal supervision. · Demonstrated strong problem solving and risk-mitigation skills. <br> <br> Direct Reports This position does not have any direct reports at the present time. It is expected that this position will be highly effective at managing and coordinating Biometrics efforts within the assigned projects for the purposes of achieving project goals. <br> <br> Physical Requirements None. <br> <br> Working Conditions Regular working condition in office area. Full time schedule is expected.</p> <p> </p> Jul 7th, 2019 08:12AM Jul 7th, 2019 08:12AM Health Care Pharmaceuticals & Biotechnology

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